Ministero dell’Università e della ricerca PRIN 2022, Clinical trial data between privatization of knowledge and Open Science (acronym: CLIPKOS)
Clinical research produces enormous amounts of data. This especially in the pharmaceutical field during pre-clinical and clinical tests. These data represent an invaluable resource from multiple points of views: scientific interests in creating new medicines and pursuing progress and innovation in the health domain, the necessity to verify the studies carried out, the purely commercial approach on protecting the effort to obtain a marketing authorisation, and the public interest in access and disclosure. Access to this information is often severely limited by forms of exclusive rights and other forms of protection and control that persist on various.
levels and make it impossible to take (public) advantage of such important resources. On the contrary, Open Science (OS), Open Access (OA), findability, accessibility, interoperability, and reuse (FAIR) principles, transparency and flexibility needs and the creation of public databases push forward the implementation of accessible or open data.
The recent pandemic has tragically brought this problem to bear and in this application context there is currently a lack of clarity and knowledge among the different stakeholders in the legal, philosophical and ethical fields.
The project aims to investigate the interplay between privatization of knowledge by pharmaceutical developers and OS for clinical trial data from multiple perspectives.
The first objective of the research will be the comprehensive legal mapping of the regulatory framework for the protection of data in clinical research in the European Union (EU) legal system and in some selected Member States, including Italy, while briefly considering the international context. It shall be also examined if and how this scenario may be consistent with the instances promoted by OS and OA. The legal analysis uses a comparative methodology that takes into account the complex regulatory framework.
The second objective will be the investigation of the different policies adopted by the public agencies (Eurpean and national) on data access and governance.
Moreover, interdisciplinarity will be key to understanding a context that sees the intersection of different scientific fields. These theoretical approaches will then be combined with ethical and philosophical studies related to striking the balance between the fundamental rights to health and science with the exclusive rights.
Ample space will also be dedicated to case studies based on health and clinical data and offered by the CNR-IFAC scientists. Researchers will be able to understand how data is managed with special reference to the concept of research integrity, data reproducibility and the attitude of communicating science in an open and transparent way.
The ultimate goals of the research are to provide a set of policy recommendations, guidelines and proposals regarding the use and disclosure of clinical test data that balance privatization and OS interests.
Jean Monnet Module on Food Law and Globalization – EU-FLAG
Matteo Ferrari is leading a Jean Monnet Module at the University of Trento. The project was funded by the European Commission in 2020 and will last for three years. The abstract of the project is available below.
Food law, a branch of the law dealing with the production and distribution of foodstuffs, is a regulatory field whose contents are to a large extent shaped by EU legislation and policies. Nonetheless, the role of EU is often underappreciated by the public and/or is blamed for neglecting national preferences; this perception is exacerbated by globalization, often considered to contribute to the disruption of local traditions. EU-FLAG will contextualize these debates, providing students and the public with a deeper understanding both of EU food law and of how it operates in a global context.
EU food law is considered one of the most advanced regulatory systems in the world. As such, it is often a point of reference for other non-EU countries; in addition, we increasingly find provisions concerning the enforcement of EU legislation outside EU borders. In this sense, EU food law strives to shape globalization. At once, EU food law operates within global dynamics and is shaped by them: 1. rules and standards created at international level are more and more incorporated into EU regulations; 2. the stringent rules characterizing EU food law can have a meaningful impact on the competitiveness of our agri-food system vis à vis non-EU ones. In order to appreciate the dialogic relationship existing between EU food law and globalization, the project will focus on some key areas of food law where such relationship is more prominent.
These general goals will be achieved by organizing: 1. a course exploring how EU food law shapes and is shaped by global dynamics; 2. an annual workshop open to professionals, public managers and the public and in collaboration with a scientific and/or civil society association.
PRIN Project – Autonomous vehicles and new technologies in transport: market design and legal issues
Giuseppe Bellantuono is leading a research unit at the University of Trento within an interdisciplinary collaboration with economists from the Universities of Bolzano/Bozen and Rome-Tor Vergata. The project was funded by the Italian Ministry for Research in 2019 and will last for three years. The abstract of the project is available below.
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Autonomous Vehicles (AVs) will deeply affect the transportation sector in the near future. They will remarkably change demand for mobility, by reducing the opportunity cost of car commute and by automatizing services that are currently requiring human intervention.
Our project analyzes two crucial aspects of the future AVs market. We study the effects of different market design choices. The presence of AVs, associated with the availability of increasingly real-time information of traffic flows, raises the potential benefits from traffic centralization. Using a theory approach, we investigate the structure of efficient tax and sets of rules, criteria and prioritization systems for road capacity allocation when travelers have heterogeneous needs and constraints. To the best of our knowledge, we are the first to apply the notion of market design in the AVs sector. Also, we provide a
complementary legal analysis of market design under AVs, using an interdisciplinary and comparative law approach. We will study how coordination among regulators in charge of different sector-specific legal regimes, as well as horizontal legal regimes (competition law, data protection law and cybersecurity law) can lead to the selection of welfare optimal business models and market design.
Technologies enable unprecedented democratization of cultural practices, and the production and use of Intellectual Property. An effective system of sustainable norms for digital copyright is needed but this is challenging to create. Copyright law is complex and there are gaps in knowledge and awareness. By bringing together researchers, libraries, copyright experts, policymakers and other stakeholders, reCreating Europe will clarify what is needed for a regulatory framework which supports culturally-diverse production, inclusive access and consumption.
Research Agreement with FBK – “Telemedicine, scientific research and Big Data: the new frontiers of digital health and the protection of personal data”
Paolo Guarda is the Principal Investigator of a collaborative research within an interdisciplinary collaboration with Fondazione Bruno Kessler and TrentinoSalute4.0.
The activity is aimed at analysing the new challenges posed by the personal data protection regulation to digital health, with particular attention to:
- the legal implications related to the use of the medical app in the context of telemedicine (or m-health), taking into accountthe Privacy by Design and Privacy by Default principles;
- the issue of the use of health data for research purposes in the era of Big Data.